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| ID | Type | Description | Link |
|---|---|---|---|
| 2009698702 | Other Identifier | Indiana University IRB |
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| Name | Class |
|---|---|
| Sonic Incytes | INDUSTRY |
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This is a cross sectional study that evaluates the relationship between LSM (liver stiffness measurement) by Liver Incytes in patients with cACLD (compensated advanced chronic liver disease) and manifestations of portal hypertension.
The purpose of this study is to assess the severity of portal hypertension in people with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplant by measuring liver stiffness with the Liver Incytes device (Velacur) and comparing the performance of LSM (liver stiffness measurement) via Velcaur and transient elastography via FibroScan to esophageal varices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Velacur by Sonic Incytes | Experimental | Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Velacur. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velacur | Diagnostic Test | Ultrasound elasticity imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) | Comparing the performance of Velacur by Sonic Incytes to transient elastography via FibroScan® in the same patient population to determine if either test is more accurate in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices. | one day |
| Platelet Count for Participants With Compensated Advanced Chronic Liver Disease | Comparing the platelet count in the same patient population to determine Velacur's accuracy in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices | one day |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Velacur Measurements to Non-Invasive Blood Markers for Predicting Advanced Fibrosis | This was initially included in our study protocol as an outcome measurement. However, we realized that these markers were not being routinely collected and the data are simply not available. Therefore, no outcome data are or can be included for this measurement. | one day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samer Gawrieh, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Division of Gastroenterolgy and Hepatology | Indianapolis | Indiana | 46202 | United States |
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70 participants enrolled in the study. The images from the Velacur device for all of the subjects were reviewed by the company. Only 33 of the enrolled participants had a valid Velacur study so results are reported only for these 33 participants. The remaining 37 participants were considered to have withdrawn from the study.
70 participants enrolled in the study. The images from the Velacur device for all of the subjects were reviewed by the company. Only 33 of the enrolled participants had a valid Velacur study so results are reported only for these 33 participants. The remaining 37 participants were considered to have withdrawn from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liver Incytes | Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Liver Incytes. Liver Incytes: Ultrasound elasticity imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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A total of 33 people underwent both Velacur and transient elastography via FibroScan and had results considered to be reliable
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| ID | Title | Description |
|---|---|---|
| BG000 | Liver Incytes | Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Liver Incytes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) | Comparing the performance of Velacur by Sonic Incytes to transient elastography via FibroScan® in the same patient population to determine if either test is more accurate in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices. | Posted | Mean | Standard Deviation | kPa | one day |
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Adverse events were collected for the duration of study participation. This is a minimal risk study with only one study visit lasting less than one hour.
The definition of adverse event utilized in this trial correlates with the clincialtrials.gov definition of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liver Incytes | Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Liver Incytes. No adverse events were reported in this minimal risk study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samer Gawrieh | Indiana University | 317-278-9326 | sgawrieh@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2021 | Jul 3, 2023 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2021 | Jul 3, 2023 | SAP_005.pdf |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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All participants will undergo quantitative ultrasound with Velacur by Sonic Incytes by a certified technician.
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This is an open label study in that all participants will receive the same study procedures. Participants only receive this Velacur intervention if they are enrolled in this trial.
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Velacur, liver stiffness | Mean | Standard Deviation | kPa |
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| Velacur, liver steatosis | Mean | Standard Deviation | dB/m |
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| transient elastography via FibroScan, liver stiffness | Mean | Standard Deviation | kPa |
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| transient elastography via FibroScan, liver steatosis | Mean | Standard Deviation | dB/m |
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| OG001 | Participants With Evidence of Esophageal Varices | Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Velacur by Sonic Incyes and transient elastography via FibroScan. All participants will have also undergone esophagogastroduodenoscopy (EGD). Results will be compared for participants with and without varices found in the EGD. |
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| Primary | Platelet Count for Participants With Compensated Advanced Chronic Liver Disease | Comparing the platelet count in the same patient population to determine Velacur's accuracy in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices | Posted | Mean | Standard Deviation | in 100000 per microliter of blood | one day |
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| Other Pre-specified | Correlation of Velacur Measurements to Non-Invasive Blood Markers for Predicting Advanced Fibrosis | This was initially included in our study protocol as an outcome measurement. However, we realized that these markers were not being routinely collected and the data are simply not available. Therefore, no outcome data are or can be included for this measurement. | During the course of this study, we realized that these markers were not being routinely collected and the data are simply not available. Therefore, no outcome data are or can be included for this measurement | Posted | one day |
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| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
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